Silver-Coated vs Standard Catheter for UTI Prevention

NCT05408533 | Completed FDA Device

• 1 other identifier: 22-004
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 2

Brief Summary

Primary Aim: To determine whether silver-coated transurethral catheter decreases the incidence of culture-confirmed urinary tract infection for women with catheter-managed urinary retention after pelvic reconstructive surgery Secondary Aims: To assess difference in bacterial uropathogens isolated in urine cultures Adverse symptoms possibly caused by silver-coated catheter

Conditions

UTI

Keywords

Silver-coated catheter; UTI; Pelvic Reconstructive Surgery; Urogynecology

Outcome Measures

Primary Outcomes (1)

• Incidence of UTIs requiring treatment

  Post-operative UTI rate

  approximately 4 weeks

Secondary Outcomes (2)

• Assess the types of bacterial uropathogens isolated from the urine cultures

  approximately 4 weeks

• Adverse symptoms possibly causes by silver-coated catheter

  approximately 4 weeks

Study Arms (2)

Silver-Coated Catheter

ACTIVE COMPARATOR

Device: 2-Way Foley Urethral Urinary Catheter

Standard Catheter

PLACEBO COMPARATOR

Device: 2-Way Foley Urethral Urinary Catheter

Interventions

2-Way Foley Urethral Urinary Catheter DEVICE

Comparing two types of catheter (silver-coated silicone versus silicone) after Pelvic Reconstructive Surgery (PRS) to compare Urinary Tract Infection (UTI) rates

Silver-Coated Catheter; Standard Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who undergo major or minor pelvic organ prolapse surgery of any compartment, or urinary incontinence surgery that are diagnosed with POUR via failed retrograde voiding trial and require an indwelling transurethral catheter upon hospital discharge. Sacral neuromodulation procedures and intradetrusor onabotulinumtoxinA (Botox) injections are excluded.

You may not qualify if:

• Unwilling or unable to participate in the study.
• Unwilling or unable to do a catheter self-removal at home.
• Inability to understand English.
• Pregnant women
• Patient personal history of urogenital anomaly, neurogenic bladder, use of chronic self-intermittent catheterization or suprapubic tubes, ureteral stents or other genitourinary indwelling devices, immunosuppressed state or chronic use of steroids.
• Currently (prior 3 months) undergoing medical management for recurrent UTI or interstitial cystitis
• Active urinary tract infection.
• Intraoperative bladder injury or cystotomy
• Physical or mental impairment that would affect the subject's ability to perceive urinary tract infection symptoms
• Reported allergy to silver metal

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (2)

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

• Lewis K, Crisp C, Ray M, Bonglack M, Carrel-Lammert M, Aldrich E, Pauls R, Hoehn J, Yeung J. Silver-Coated Foley Catheters to Reduce UTIs: A Randomized Clinical Trial. Urogynecology (Phila). 2025 Mar 1;31(3):276-284. doi: 10.1097/SPV.0000000000001634. Epub 2025 Jan 2.

  PMID: 39744866 DERIVED

Study Officials

• Jennifer Yeung, DO

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: June 7, 2022
• Study Start: June 14, 2022
• Primary Completion: February 16, 2024
• Study Completion: May 1, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)